Test, Cystatin C

Device Code: 632

Product Code(s): NDY

Device Classification Information

• Device Type ID: 632
• Device Name: Test, Cystatin C
• Regulation Description: Creatinine Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.1225 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NDY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-203 CLSI GP42-A6 (Formerly H04-A6)
  Procedures And Devices For The Collection Of Diagnostic Capillary Blood Specimens; Approved Standard -- Sixth Edition

Total Product Life Cycle

• Device Type ID: 632
• Device: Test, Cystatin C
• Product Code: NDY
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Creatinine Test System.
• CFR Regulation Number: 862.1225 [🔎]

Premarket Reviews
Manufacturer	Decision
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS OPERATIONS (RDO)
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS OPERATIONS, INC
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
High Test Results	4
Total Device Problems	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Tosoh Bioscience Inc	II	Jun-05-2018

TPLC Last Update: 2019-04-02 19:37:52